WO2020251788A1 - Dispositif et procédé d'occlusion intracrânienne orientable - Google Patents

Dispositif et procédé d'occlusion intracrânienne orientable Download PDF

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Publication number
WO2020251788A1
WO2020251788A1 PCT/US2020/035489 US2020035489W WO2020251788A1 WO 2020251788 A1 WO2020251788 A1 WO 2020251788A1 US 2020035489 W US2020035489 W US 2020035489W WO 2020251788 A1 WO2020251788 A1 WO 2020251788A1
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WIPO (PCT)
Prior art keywords
catheter
stent
delivery catheter
distal end
packaging
Prior art date
Application number
PCT/US2020/035489
Other languages
English (en)
Inventor
Daniel Ezra WALZMAN
Original Assignee
Walzman Daniel Ezra
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US16/852,488 external-priority patent/US11045177B2/en
Priority claimed from PCT/US2020/035017 external-priority patent/WO2020251777A1/fr
Application filed by Walzman Daniel Ezra filed Critical Walzman Daniel Ezra
Priority to EP20823441.9A priority Critical patent/EP3982841A4/fr
Priority to JP2021574225A priority patent/JP2022542763A/ja
Priority to CN202080043482.2A priority patent/CN114206228A/zh
Priority claimed from US16/888,813 external-priority patent/US11638655B2/en
Publication of WO2020251788A1 publication Critical patent/WO2020251788A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/12036—Type of occlusion partial occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/068—Modifying the blood flow model, e.g. by diffuser or deflector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/823—Stents, different from stent-grafts, adapted to cover an aneurysm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A61F2230/0023—Angular shapes triangular
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0023—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity

Definitions

  • the present disclosure relates to medical devices used to treat aneurysms and fistulas within unhealthy blood vessels, more particularly, to endovascular devices, including flow-diverting, covered, caped, fenestrated, branched, and other variable-porosity stents for use in
  • the prior art teaches the use of a number of devices to treat aneurysms.
  • One such device is a differentially porous stent, having asymmetrical braiding or coils, so as to create areas of lesser or greater blood flow as may be desired.
  • Fenestrated and branched devices have been effectively employed in the aorta and its immediate branches, and other applications having larger blood vessels with little tortuosity.
  • prior art has disclosed the theoretical application of such devices intracranially and in other tortuous and distal vasculature, no device or method has been described that can reliably deploy such devices in their desired radial orientation. The constraints of intracranial or other tortuous vasculature have to date precluded the use thereof in these areas.
  • U.S. Pat. Publ. No. 2019/0151072 A1 (Walzman) teaches a caped stent providing a cover having a single attachment point and a free end that can be overlapped, thereby providing better conformity to target vessels than existing covered stents.
  • an endovascular device may provide additional porosity by including a fenestration, allowing no obstruction whatsoever of blood flow to the origin of a branch vessel. This may be combined with a full cover, in the extreme embodiment, at or near an opposing side to cut blood flow to a target aneurysm or fistula altogether.
  • the stent-assisted coiling also has some of the same short comings related to stent placement and placing a stent in the parent artery requires prolonged use of anti-platelet agents to reduce the risk of thrombosis-based stenosis within the stent.
  • Some aneurysms and fistulas are ideally treated with covered stents, which can most directly cover the hole of the fistula or the neck of the aneurysm and reconstruct the vessel wall, immediately redirecting blood flow into the normal path of the parent vessel.
  • covered stents there is no covered neuro-stent currently available in the United States.
  • the U.S. Food and Drug Administration (FDA) has examined and tested such covered neuro-stents but none has "FDA approval," which means that the FDA has not decided the benefits over the existing treatment options outweigh the potential risks for the item's planned use.
  • FDA Food and Drug Administration
  • covers stents that are effective in severely tortuous anatomy in other parts of the body, including but not limited to splenic artery aneurysms and pulmonary arteriovenous fistulas.
  • prior art teaches the use of flow diversion devices to divert flow away from the aneurysm by placing a mesh stent or a structure similar to a stent, on the aneurysm neck along the parent artery.
  • the use of these devices allows for thrombus formation inside the aneurysm.
  • increased technical complications can develop following the deployment of flow diverters.
  • Most covered stents involve producing a cylinder of a stent "skeleton" or “frame” out of semirigid materials such as metal alloys, and then attaching an impermeable "cover” to said frame.
  • the prior art teaches such attachments are diffuse and located throughout the covering of a stent, along fixed intervals of said covering and frame, and consequently significantly limit flexibility of the device.
  • a device could be built that includes multiple branches, through multiple fenestrations, provided all fenestrations are in proper relative distance and orientation to the native branches.
  • Ruiz discloses the building of a directional sheath or catheter in vivo, rather than an implant. Like the Berez device, however, the Ruiz device can work easily in straight anatomy of short distances, where a catheter can easily and accurately be rotated along its entire length from its proximal hub. [00023] Rotation is not effective for positioning in tortuous and/or longer vascular anatomies, in which catheters do not respond in a similarly predictable fashion.
  • a stent device which is usually crimped for delivery, is advanced into a delivery catheter, typically using a delivery wire and/or hypotube, in a particular arrangement.
  • the stent will exit the delivery catheter in an unpredictable arrangement or orientation.
  • the present invention discloses some embodiments that may incorporate a hypotube rather than a solid wire to cross the stenosis and act as a rail for subsequent delivery of angioplasty balloons and stents.
  • a hypotube may additionally be capable of delivering fluids therethrough, thereby reducing the sump effect on the brain from flow reversal, while still maintaining sufficient retrograde flow to overcome any flow from the external carotid artery and maintain retrograde flow across the lesion during angioplasty and stenting, to minimize the risk of distal intracranial emboli.
  • a stent optionally having a free-floating cover.
  • Said floating cover is designed to optimize insertion in tortuous anatomy.
  • a single circumferential attachment point at one end (as small as 1 nm), overlapping circumferential shingles and overlapping geometric shingles.
  • the disclosed device may optionally be deployed under flow arrest, via pharmacologic means, or via delivery through a balloon guide catheter with temporary balloon inflation or other means, to minimize the possibility of blood flow affecting positioning as it is unsheathed.
  • irrigation through an angioplasty balloon and/or its delivery catheter may be possible.
  • an additional balloon mounted on an angioplasty balloon catheter and/or the wire or hypotube, or a separate balloon may serve to occlude the carotid artery distally during portions of the procedure, to prevent distal emboli while minimizing sumping of flow from the brain. Flow reversal can then be applied for a shorter duration during and after balloon deflation.
  • a series of angioplasty balloons and/or stent(s) and their delivery catheters may be delivered sequentially over each other, over the prior, to minimize the number of device exchanges required, thereby reducing procedural times and associated risks.
  • the present invention also discloses the embodiments noted above in the form of branching stents.
  • Additional embodiments may include Y configuration stents, in which the first stent has increased porosity with larger pores over the origin of a branch vessel, and the second stent, which traverses said larger pores over the origin of the branch vessel, has increased porosity where it crosses the primary vessel in which the primary stent is placed.
  • FIG. 1A shows a perspective view of a cylindrical delivery catheter 330 having a triangularly shaped lumen 1.
  • FIG. IB shows an embodiment of delivery catheter lumen 3 without its cylindrical sheathing (not shown), having a proximal end 1 and a distal end 2, and has been passed through vessel 1000 such that distal end hole 2 in proximal to target aneurysm 2000.
  • FIG. 1C is a cutaway view of delivery catheter lumen 3 having a triangular lumen with ABC angles, and pusher wire 300 passing therethrough at offset C-A-B angles, in order to deliver a differentially porous occlusion device (not shown) at a 120° angle to deploy at a desired orientation.
  • FIG. 3 shows push-wire 300 and stent 301 disposed at push-wire distal end 303 within vessel walls 1000 following removal of delivery catheter lumen 3 (shown in FIG. 2).
  • FIG. 4 shows an interior view of delivery catheter lumen 3 having a triangular shape, composed of proximal sides 4, 5 and 6, corresponding with distal sides 44 (oblique distal sides 55 and 66 behind 44 are shown in FIG. 5); facing side 444 illustrates the full length of the catheter side beginning at proximal side 4 and ending in distal side 44.
  • Alternative embodiments may employ other regular shapes such as rectangles or stars.
  • FIG. 5 shows an adjacent face 555 of the interior of delivery catheter of FIG. 4 (or FIG. 4 rotated once 120.), face 555 beginning at proximal side 5 and ending in distal side 55 (oblique distal sides 44 and 66 behind 55 shown in dashed cutaway); facing side 555 further includes radio-opaque orientation-aid markers 5550.
  • FIG. 6 shows a stent 301 attached to push-wire 300 at distal end 303 of push-wire 300 and proximal end of stent 301.
  • Said stent 301 is triangular in shape, with distal end 3010 and triangular edges on a plane with distal end 303, namely edges 334, 355 and 366.
  • triangular edge 3550 is shown in dotted lines disclose the other two triangular edges 3440 and 3660.
  • Triangular edge 335 forms a planar length terminating in edge 3550. On said plane, resides radio-opaque markers 55500.
  • FIG. 7 A and FIG. 7B show delivery catheter lumen 3 geometry with relative position of radio opaque markers.
  • FIG. 8 shows one geometry of a pusher wire
  • FIG. 9 shows packing catheter.
  • FIG. 10 shows options for packing catheter.
  • FIG. 13 and FIG. 14 show optional embodiments of reverse unsheathing stents.
  • FIG. 1A a perspective view is shown of a cylindrical delivery catheter 330 having a triangularly shaped lumen 1.
  • the present invention discloses a traditional cylindrical delivery catheter with a linear lumen such as a triangle, square, other rectangle, star, hexagon or so on. Said linear lumen is designed to allow the second of a push wire which has a similar shape, adapted to be inserted into said lumen 1 at differing, fixed relative positions.
  • FIG. IB shown is an embodiment of delivery catheter lumen 3 without its cylindrical sheathing (not shown).
  • Said delivery catheter lumen 3 having a proximal end 1 and a distal end 2, and has been passed through vessel 1000 such that distal end hole 2 in proximal to target aneurysm 2000.
  • Delivery catheter lumen 3 is inserted into blood vessel 1000 until stopped such that distal end 2 is proximal to target aneurysm 2000. Due to the linear geometry of the lumen 1, the delivery catheter lumen 3 has a set orientation with respect to having one side closest to said target aneurysm 2000.
  • FIG. 1C shown is a cutaway view of delivery catheter lumen 3 having a triangular lumen with A-B-C angles, and pusher wire 300 passing therethrough at offset C-A-B angles, in order to deliver a differentially porous occlusion device (not shown) at a 120° angle to deploy at a desired orientation.
  • the present invention teaches that the orientation of a push- wire may be fixed outside the patient's body by fixing its relative orientation with respect to the delivery catheter lumen 3.
  • Said delivery catheter lumen 3's orientation with respect to target aneurysm 2000 having been established prior to insertion of push-wire 300, allows the user of the device of the present invention to properly insert said push- wire 300 to achieve proper orientation with respect to aneurysm 2000 without turning said push- wire 300 inside the patient.
  • the present disclosure includes the basic concept of having a non-circular, geometrically shaped inner lumen and matched pusher wire or hypotube. This allows the user to avoid unwanted turns of devices inside the delivery catheter and inside of vessels.
  • It also allows delivery in a predictable radial orientation, utilizing a marker at the hub and a corresponding radial marker at the delivery catheter tip, so that when the orientation of the delivery catheter tip is imaged after positioning intracranial, or in similar tortuous anatomy, the degree of torsion, if any, relative to the corresponding hub marker and relative to the target pathology can be measured.
  • the stent device can then be inserted at an appropriate orientation relative to the hub marker, so that the desired orientation is delivered to the target vessel.
  • the device/stent can be inserted knowing that whatever porosity is inserted at the hub at 12 o'clock, will consistently be delivered through the catheter tip at 4 o'clock.
  • stent devices can be preloaded in packaging catheters of a similar geometric shape, and with a similar 12 o'clock marker (or similar), at various radial circumferential orientations relative to the 12 o'clock position. Then, depending on which orientation is desired, the appropriate preloaded device can be chosen and utilized.
  • the devices can all be preloaded in the same orientation, and the packaging catheter can be rotated at various angles relative to the delivery catheter and its hub, in order to achieve the desired orientation of the stent device as it is transferred from the packaging catheter to the delivery catheter.
  • the packaging catheter it typically shorter than the delivery wire or delivery hypotube.
  • the stent is preloaded onto said delivery wire or hypotube within said packaging catheter. Transfer of said stent device is then achieved by mating the packaging catheter with the delivery catheter, within the hub of the delivery catheter, and then advancing/pushing the back of the wire/hypotube, which is extending out the back of the packaging catheter.
  • wire/hypotube is advanced, together with the stent mounted thereon, at a minimum until the stent is completely within the delivery catheter, and most often until the majority of the pusher wire/hypotube is as well.
  • the packaging catheter is the removed from the remainder of the hypotube/wire, and the operator continues to push said hypotube/wire until the stent reaches the end of the delivery catheter.
  • the stent can then be deployed by pushing it out, retracting the delivery catheter to unsheathe it, and/or a combination of these.
  • Packaging catheter 30 is joined to hub 700 at port 701 such that stent 301 and push- wire 300 are oriented as desired so as to present the minimally porous surface of said stent 301 substantially toward the target aneurysm 2000.
  • FIG. 4 shows a triangular shape having sides 4, 5 and 6 on the proximal end, 44 at the distal end of face 444.
  • Alternative embodiments may employ other regular shapes such as rectangles or stars.
  • FIG. 5 shown is an adjacent face 555 of the interior of delivery catheter of FIG. 4 (or FIG. 4 rotated once 120.), face 555 beginning at proximal side 5 and ending in distal side 55 (oblique distal sides 44 and 66 behind 55 shown in dashed cutaway); facing side 555 further includes radio-opaque orientation-aid markers 5550.
  • FIG. 5 is a rotated image of FIG. 4 displaying the opposing plane 555 which terminates at side end 5 on the proximal end, and 55 on the distal end.
  • radio markers 5550 allow the user to ascertain the relative orientation of one side of the delivery catheter lumen 3.
  • the packaging catheter 30 may be properly oriented in hub port 701 such that when push-wire 300 and stent 301 are proximal to aneurysm 2000, they are properly aligned or oriented.
  • a delivery catheter with a " 12 o'clock" marker at the proximal hub of said catheter Use a delivery catheter with a " 12 o'clock" marker at the proximal hub of said catheter.
  • the 12 o'clock marker may be disposed on the hub and on the delivery catheter tip (i.e., radio opaque on the catheter tip).
  • the user inserts the stent-packaging catheter having a differentially porous stent or occlusion device mounted on a push- wire therein. After testing, the user rotates the packaging catheter at the hub to the desired indicator.
  • the orientation can be confirmed with an additional test stent/device which is temporarily advanced in the predicted orientation, and then imaging can confirm, before the test device is removed and a permanent device is advanced and deployed.
  • a test result shows a fenestration deploys at "7 o'clock", which is 90° clockwise relative to the target branch vessel. The treatment would then reorient the stent packaging catheter at "4 o'clock", to have it appear correctly oriented proximal to the target branch.
  • the stent loaded in the appropriate orientation relative to the similarly disposed hub marker can be deployed.
  • "test" device/stents with additional radio-opaque markers can be retrievably deployed to confirm the orientation.
  • the surface of the delivery catheter will be conventionally cylindrical, substantially rounded, to facilitate advancement through circulatory vessels.
  • An unrounded lumen minimizes the rotational tendency of a deploying stent-packaging catheter, or a wire, enhancing the predictability of orientation.
  • a square, hexagon, octagon, pentagon, a "house” silhouette or star shape Alternatively, a square, hexagon, octagon, pentagon, a "house” silhouette or star shape. Any style of star may be used, such as 6-pointed, "Star of David” or others, or other geometric shapes, provided a single one is used throughout the lumen.
  • a packaging catheter may be shaped correspondingly to the shape of the lumen of the delivery catheter. This correspondence is shown in the accompanying FIGs. 1A and IB, for example.
  • This embodiment is configured such that the correspondingly shaped packaging catheter and delivery wire/hypotube are snug enough so as to not allow rotation, but loose enough to allow movement back and forth relative to one another. This embodiment will maintain a similar orientation through the advancement of the stent/device through the delivery catheter, allowing accurate and predicable deployment in appropriate and desired orientations.
  • a " 12 O'clock" marker that is at the same orientation can be on the hub and on the catheter tip (radio-opaque on the catheter tip).
  • the stent loaded in the appropriate orientation relative to the similarly disposed hub marker can be used.
  • "test" device/stents with additional radio-opaque markers can be retrievably deployed to confirm the orientation.
  • the tip marker orientation can be well imaged after delivery intracranially, or into similar tortuous vasculature, the tip marker orientation, and its relative deflection on a rotary basis from the hub marker, can most often be used to determine rotational orientation, without the need for optional retrievable test-stent devices.
  • a fenestration can be accurately deployed at the origin of a branch vessel. Then a wire can be advanced through that fenestration and into the branch, and either: (a) a balloon expandable device/stent can be delivered over the wire and deployed so that the proximal end minimally overlaps with the fenestration of the first stent/device; moreover, the branch may also optionally have a taper so it is somewhat larger at the fenestration side versus the portion that extends into the branch vessel; (b) a second delivery catheter (or the first can be re-used) can be delivered into the branch (the wire can optionally be removed) and an additional branch stent, most often self-expanding, can be delivered through the delivery catheter.
  • the branch stent may also optionally have a taper so it is somewhat larger at the fenestration side versus the portion that extends into the branch vessel.
  • Delivery method (b) has difficulty accurately landing the proximal stent, especially with "woven” or “braided” stents which can significantly, and unpredictably, foreshorten during deployment (compared to their length crimped in the delivery catheter).
  • Another option therefore is a novel delivery device for such stents. In this embodiment, it can be loaded in a device/catheter similar to the "inner catheter with wings" of a filter-tip
  • a single or multiple external wires attached to a stent in a preferred embodiment ideally attached to the proximal and distal ends of the stent (which can be "over the wire” or most ideally “rapid exchange") once a first stent is deployed with the fenestration overlying a branch vessel origin, a second wire is advanced through the fenestration into the branch, and a second stent/device, delivered constrained within said retaining structure and having at least one second wire attached to said stent outside the central tube and/or an outer tube attached to said stent, is advanced over the wire to the desired position.
  • the stent attached wire(s) (or, alternatively, the outer catheter) is held in place while the "inner catheter with wings" is advanced, exposing/unsheathing the stent from the proximal end first.
  • the present invention also discloses an unsheathing device for the branch stent. More specifically the present invention teaches a device which un-sheaths the proximal part first.
  • the wires can expand with the stent. If the stent is attached to an outer catheter (which is outside the inner catheter, but still inside the stent; the wings are outside the stent), it would need to wait until entire stent is unsheathed before detaching the proximal end.
  • stent is attached circumferentially proximally to an outer catheter and also has at least one additional wire attached to the stents distal segment- or additional attachment(s) to the outer catheter at the distal stent segment
  • the proximal attachments can be detached upon unsheathing the proximal segment of the stent- to ensure appropriate orientation and position overlapping minimally the fenestration but not significantly overlapping/covering the primary vessel, and then the distal stent can be detached once the entire stent is deployed.
  • the stent can optimally be attached only distally to the "outer catheter", in order to advance the system, the outer catheter is pushed, which pulls the attached stent and pushes the winged portion of the inner catheter (and subsequently the entire inner catheter in unison). Then, when the stent is properly positioned, the second stent can be unsheathed by holding the outer catheter (with attached stent) in position and then advancing the inner catheter, which will unsheath the proximal stent first. Using self-expanding stents, the proximal stent will automatically expand as it is unsheathed. If position is off, the inner catheter can be pulled back again and the proximal stent can be re-sheathed, and the stent can be repositioned before unsheathing again.
  • the proximal end of stent can have a nitinol wire ring to encourage more immediate opening/self-expansion to its maximal diameter.
  • Such rings may optionally be repeated at additional intervals along the stent device.
  • a preferred method may be described by the following steps, using the embodiment of the device in which the pusher wire comprises an angular shape congruent with the angular lumen of the delivery catheter (e.g., a triangularly shaped pusher wire and triangular lumen): (a) inserting said delivery catheter into a body,
  • a "Y" shaped stent may be assembled from two stents in vivo by reference to markers.
  • the present invention may have branched stent elements.
  • the present invention's stent elements may optionally be fully re-sheathable.
  • the present invention's stent elements may optionally be partly re-sheathable.
  • All stent elements of the present invention may be optionally be detachable.

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  • Transplantation (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un procédé et un dispositif servant à orienter correctement un dispositif d'occlusion intracrânienne, tel qu'une endoprothèse présentant une porosité différentielle, par rapport à des zones souhaitées de flux sanguin supérieur ou inférieur (par exemple, des vaisseaux ramifiés et des anévrismes, respectivement), ledit dispositif étant en particulier conçu pour être utilisé dans le traitement d'anévrismes, notamment dans le système vasculaire intracrânien. L'invention concerne également un dispositif intravasculaire comprenant un cathéter d'administration comportant une embase et une lumière angulaire apte à contraindre un fil-poussoir à l'intérieur d'un cathéter d'emballage pour déployer ladite endoprothèse selon une orientation, la zone de porosité minimale venant en butée contre l'anévrisme, et la zone de porosité maximale permettant la circulation du sang dans une ramification ou un autre vaisseau. Un procédé d'utilisation de ce dispositif est également décrit.
PCT/US2020/035489 2019-06-12 2020-05-31 Dispositif et procédé d'occlusion intracrânienne orientable WO2020251788A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP20823441.9A EP3982841A4 (fr) 2019-06-12 2020-05-31 Dispositif et procédé d'occlusion intracrânienne orientable
JP2021574225A JP2022542763A (ja) 2019-06-12 2020-05-31 配置の向きを制御可能な頭蓋内閉塞器具および方法
CN202080043482.2A CN114206228A (zh) 2019-06-12 2020-05-31 可定向的颅内封堵器和方法

Applications Claiming Priority (10)

Application Number Priority Date Filing Date Title
US201962921378P 2019-06-12 2019-06-12
US62/921,378 2019-06-12
US201962921574P 2019-06-25 2019-06-25
US62/921,574 2019-06-25
US16/852,488 US11045177B2 (en) 2016-11-02 2020-04-19 Orientable intracranial occlusion device and method
US16/852,488 2020-04-19
USPCT/US2020/035017 2020-05-28
PCT/US2020/035017 WO2020251777A1 (fr) 2019-06-12 2020-05-28 Dispositif et procédé d'occlusion intracrânienne orientable
US16/888,813 US11638655B2 (en) 2016-11-02 2020-05-31 Orientable intracranial occlusion device and method
US16/888,813 2020-05-31

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US11723785B2 (en) 2016-12-05 2023-08-15 Daniel Ezra Walzman Orientable intracranial occlusion device and method

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11638655B2 (en) 2016-11-02 2023-05-02 Daniel Ezra Walzman Orientable intracranial occlusion device and method
US11723785B2 (en) 2016-12-05 2023-08-15 Daniel Ezra Walzman Orientable intracranial occlusion device and method

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